NCT05306873

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients. Treatment effects will be evaluated within the individual immunologically-homogenous subsets defined at screening. This study will also explore and compare pre-randomization gene expression patterns among responders and non-responders to MMF and MMF plus voclosporin, use comprehensive immunophenotyping to study the immunologic changes that accompany treatment- induced disease improvement and to better understand immunologic changes associated with the loss of clinical response.

Detailed description

The study was conducted in 3 stages with a maximum participant follow-up time of 56 weeks. Stage 1 was a treatment withdrawal period lasting up to 4 weeks where consenting participants receive up to 3 intramuscular injections of a long-acting corticosteroid to achieve amelioration of symptoms. In addition, participants withdraw from all other treatments for lupus with the following exceptions: (i) as needed (PRN) nonsteroidal anti-inflammatory treatments may be started or continued, (ii) PRN topicals may be continued, (iii) hydroxychloroquine, chloroquine, or quinacrine may be continued at any stable dose, and (iv) prednisone, if\<= 10 mg/day, may be continued at stable doses but not started. Qualifying participants from Stage 1 were randomized (1:1) into Stage 2 to receive either MMF or placebo for MMF for up to 48 weeks. Participants who experienced a Stage 2 treatment failure at or before the Week 24 visit and a corticosteroid injection was deemed sufficient for treatment without new or increased lupus medication were eligible to re-randomize (1:1) into Stage 3 to receive either MMF + Voclosporin or MMF + Placebo for Voclosporin for up to 24 Weeks. Participants who did not experience a Stage 2 treatment failure at or before the Stage 2 Week 48 visit were to return for an End of Study/Safety Follow-up visit 4 weeks after the final dose of study-provided medication. Similarly, participants who did not experience a Stage 3 treatment failure at or before the Stage 3 Week 24 visits were asked to return for an End of Study/Safety Follow-up visit 4 weeks after the final dose of study provided medication.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	Stage 2 Dosing: Week 1: Participants will receive 500mg MMF/Placebo twice daily Week 2: Participants will receive 500mg/Placebo in the morning and 1,000mg MMF/Placebo in the evening Weeks 3-48: Participants will receive 1000mg MMF/Placebo twice daily
DRUG	Placebo for Mycophenolate Mofetil	Stage 2 Dosing: Week 1: Participants will receive 500mg MMF/Placebo twice daily Week 2: Participants will receive 500mg/Placebo in the morning and 1,000mg MMF/Placebo in the evening Weeks 3-48: Participants will receive 1000mg MMF/Placebo twice daily
DRUG	Voclosporin	Weeks 1-24: 23.7 mg Voclosporin (3 x 7.9 capsules) twice daily
DRUG	Placebo for Voclosporin	Weeks 1-24: 23.7 mg Placebo for Voclosporin (3 x 7.9 capsules) twice daily
DRUG	Mycophenolate Mofetil	Stage 3 Dosing: Participants who received placebo MMF in Stage 2: * Week 1: Participants will receive 500mg MMF plus matching placebo for MMF (to appear like a 1000mg dose) twice daily * Week 2: Participants will receive 500mg plus matching placebo for MMF (to appear like a 1000mg dose) and 1000mg in divided doses * Weeks 3-24: 1000mg MMF twice daily Participants who received MMF in Stage 2 • Week 1-24: 1000mg MMF twice daily

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-06-13
• Completion: 2024-07-11
• First posted: 2022-04-01
• Last updated: 2025-09-09
• Results posted: 2025-09-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study